Effectiveness of a Hybrid Cardiac Rehabilitation Program

NCT05868343 | Active Not Recruiting

• 1 other identifier: 101745
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this pragmatic randomized clinical trial is to compare the effectiveness of a hybrid model of cardiac rehabilitation with a centre-based program in people with cardiovascular disease. The main question it aims to answer is: • How effective is a hybrid model of CR for people with cardiovascular disease living in a francophone minority community compared to a centre-based model of CR in terms of leading to maintenance of gains (physical activity level, functional capacity, mental health, quality of life) six months after CR? Participants will undergo a 12-week hybrid cardiac rehabilitation program. For the first six weeks, patients will be required to attend the hospital twice a week. After that, there will be a gradual increase in home sessions for the remaining six weeks. When a patient has a home session, health professionals will follow up with a weekly phone call. Researchers will compare the centre-based cardiac rehabilitation program with the hybrid program to see if the hybrid program can better maintain the level of physical activity, mental health, functional capacity, and quality of life six months after the end of the program.

Conditions

Cardiovascular Diseases

Keywords

Cardiac Rehabilitation; Hybrid; Randomized controlled trial; Physical Activity; Long term

Outcome Measures

Primary Outcomes (1)

• Change in level of Physical Activity

  Description: The Level of Physical Activity will be collected using the International Physical Activity Questionnaire (IPAQ).

  Questionnaire will be completed at 0 months, 3 months and 9 months

Secondary Outcomes (3)

• Change in health-Related Quality of Life

  Questionnaire will be completed at 0 months, 3 months and 9 months

• Change in functional Capacity

  Questionnaire will be completed at 0 months, 3 months and 9 months

• Change in anxiety and Depression

  Questionnaire will be completed at 0 months, 3 months and 9 months

Study Arms (2)

Center-based cardiac rehabilitation program

ACTIVE COMPARATOR

Other: Center-based Cardiac Rehabilitation Intervention

Hybrid cardiac rehabilitation program

EXPERIMENTAL

Other: Hybrid Cardiac Rehabilitation Intervention

Interventions

Center-based Cardiac Rehabilitation Intervention OTHER

The center-based cardiac rehabilitation program is 12 weeks in length. Participants will travel to the center twice a week for the duration of the program. Participants receive an individualized exercise program to be completed at the center according to Canadian recommendations. Twelve pre-recorded educational vignettes on various health topics and two group educational sessions on nutrition are offered to participants in person during the first twelve sessions at the center. In addition, at the beginning of the CR program, participants watch a motivational vignette from one of our patient partners about the importance and benefits of following the CR program. Depending on the needs of each participant, they may be referred to various external clinics within the Vitalité network, such as the Nutrition Service.

Center-based cardiac rehabilitation program

Hybrid Cardiac Rehabilitation Intervention OTHER

The center-based cardiac rehabilitation program is 12 weeks in length. For the first six weeks, participants are required to attend the hospital twice a week. After that, there will be a gradual increase in home sessions for the remaining six weeks. When a patient has a home session, health professionals follow up with a phone call.Twelve pre-recorded educational vignettes on various health topics and two group educational sessions on nutrition are offered to participants in person during the first twelve sessions at the center. In addition, at the beginning of the CR program, participants watch a motivational vignette from one of our patient partners about the importance and benefits of following the CR program. Depending on the needs of each participant, they may be referred to various external clinics within the Vitalité network, such as the Nutrition Service.

Hybrid cardiac rehabilitation program

Eligibility Criteria

• Age: 19 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be and adult (over 19 years old)
• Be eligible for Vitalité Health Network Cardiac rehabilitation program.

You may not qualify if:

• Have a physical or cognitive condition that precludes participation in an exercise program.
• Have previously participated in a CR program.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (9)

Hôpital régional Chaleur

Bathurst, New Brunswick, Canada

Location

Centre J.K. Irving

Bouctouche, New Brunswick, Canada

Location

Hôpital Régional de Campbellton

Campbellton, New Brunswick, Canada

Location

Hôpital de l'Enfant-Jésus RHSJ

Caraquet, New Brunswick, Canada

Location

Hôpital régional d'Edmundston

Edmundston, New Brunswick, Canada

Location

Hôpital général de Grand-Sault

Grand Falls, New Brunswick, Canada

Location

Coeur en santé

Moncton, New Brunswick, Canada

Location

Hôtel-Dieu Saint-Joseph de Saint-Quentin

Saint-Quentin, New Brunswick, Canada

Location

Hôpital de Tracadie

Tracadie, New Brunswick, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Pamela Tanguay

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: First, the centers are randomized to begin the trial period by offering all their patients either hybrid CR or traditional CR. After recruiting half of the target patient population to be included in the study, centers will switch to offering the other type of CR to their new patients admitted from that point on.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 22, 2023
• Study Start: May 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: August 31, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9)